Ito Co., Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Ito Co., Ltd.” (first 1999, latest 2021), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 128 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 155 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ito Co., Ltd. took a median 155 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 162 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 2 | 2 |
| ITH | Equipment, Traction, Powered | 2 | 2 |
| BWK | Stimulator, Electro-Acupuncture | 1 | 1 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| NUW | Stimulator, Muscle, Powered, Dental | 1 | 1 |
Review panels
- Physical Medicine (6)
- Dental (1)
- Neurology (1)
Most recent Ito Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203525 | D function | NUW | 2021-05-05 | 155 |
| K112520 | US-101L, US-103S | IMI | 2011-10-26 | 56 |
| K081943 | MODEL ES-130 | BWK | 2008-11-24 | 139 |
| K081247 | TM-400 | ITH | 2008-08-25 | 116 |
| K032793 | US-100 PORTABLE ULTRASOUND THERAPY UNIT | IMI | 2003-10-09 | 30 |
| K022846 | SW-180 SHORTWAVE THERAPY UNIT | IMJ | 2003-01-28 | 154 |
| K990787 | TRIO 300 | IPF | 1999-10-20 | 224 |
| K992545 | TM-300 TRACTION SYSTEM | ITH | 1999-09-01 | 33 |
Recalls
openFDA lists no recalls under a recalling firm named Ito Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ito Co., Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Ito Co., Ltd.” (first 1999, latest 2021), across 6 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ito Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ito Co., Ltd. is 128 days.
Which FDA product codes appear under Ito Co., Ltd.?
The most frequent FDA product codes under this applicant name are IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat, 2); ITH (Equipment, Traction, Powered, 2); BWK (Stimulator, Electro-Acupuncture, 1).
Next steps
- See all 8 Ito Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IMI, Ito Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.